Safety and Efficacy of Finerenone in Metabolic Dysfunction Associated Steatotic Liver Disease(MASLD/NAFLD) Related Cirrhosis Patients With Ascites in Prevention of Chronic Kidney Disease.

NCT07585526 | Not Yet Recruiting

• 1 other identifier: ILBS-MASLDCKD-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Renal dysfunction is a frequent and clinically important complication in cirrhosis, and MASLD/NAFLD is associated with increased risk of incident CKD; however, finerenone has not been specifically studied in MASLD-cirrhosis populations despite proven cardiorenal benefits in diabetic CKD. This monocentric, open-label, randomized controlled trial at the Department of Hepatology, ILBS, New Delhi will enroll 160 adults (18-80 years) with MASLD/NAFLD cirrhosis, clinical grade I-II ascites, and stable eGFR ≥60 mL/min/1.73 m² (MDRD-6), with key exclusions including CTP class C, refractory ascites, significant coagulopathy, intrinsic kidney disease, recent major cardiovascular events, and other protocol-defined contraindications. Participants will receive standard medical treatment (dietary measures, diuretics as indicated, metabolic control, complication management, albumin/beta-blockers as needed) and will be randomized to finerenone (5 mg/day uptitrated to 10-20 mg/day) versus spironolactone (50 mg/day uptitrated to 100-200 mg/day). The primary endpoint is incident CKD at 6 months , defined as sustained eGFR \<60 mL/min/1.73 m² over 3 months. Secondary endpoints include MAKE/MACE/MALO at 6 months, drug-related adverse events (including hyperkalemia, hyponatremia, hypotension, hyperuricemia), AKI/AKD episodes, renal biomarkers (e.g., cystatin C, UPCR), ascites response, liver severity scores (MELD 3.0/MELD-Na/CTP), and metabolic/inflammatory/endothelial markers (e.g., HbA1c, HOMA-IR, hsCRP, vWF). Sample size (n=160; 80/arm) is powered to detect an absolute 20% reduction in CKD progression (35% to 15%) with 80% power and 5% alpha (10% dropout), with intention-to-treat analyses including Kaplan-Meier and Cox regression methods.

Conditions

MASLD; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Incidence of chronic kidney disease (CKD) in patients with MASLD/NAFLD related cirrhosis with clinical ascites at 6 months between both the groups, defined as:

  CKD diagnosis will be based on either of below criteria: 1. Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m² or 2. ≥30% decline in eGFR from baseline,assessed using the CKD-EPI equation.

  6 months

Secondary Outcomes (6)

• Incidence of hyperkalemia/hyponatremia/hypotension/hyperuricemia.

  6 months

• Incidence of Acute Kidney Injury (AKI) - Number and proportion of participants developing Acute Kidney Injury - Based on KDIGO criteria (increase in serum creatinine ≥0.3 mg/dL in 48 hours or ≥1.5× baseline within 7 days) .

  6 months

• Incidence of Acute Kidney Disease (AKD) - Number and proportion of participants developing Acute Kidney Disease (Kidney dysfunction lasting 7-90 days after AKI or de novo).

  6 months

• Change in Model for End-Stage Liver Disease Sodium (MELD-Na) score- Mean change from baseline in MELD-Na score.

  6 months

• Change in Child-Turcotte-Pugh (CTP) score - Mean change from baseline in Child-Turcotte-Pugh score

  6 months

Study Arms (2)

Finerenone+SMT

EXPERIMENTAL

finerenone 5 mg/day followed by 10 mg/day. Dose will be increased as necessary up to 20mg/day + SMT.

Drug: Finerenone; Other: Standard Medical Treatment

Spironolactone+SMT

ACTIVE COMPARATOR

Spironolactone 50mg/day followed by 100mg/day,Dose will be increased as necessary up to 200mg/day + SMT.

Drug: Spironolactone; Other: Standard Medical Treatment

Interventions

Finerenone DRUG

finerenone 5 mg/day followed by 10 mg/day. Dose will be increased as necessary up to 20mg/day.

Finerenone+SMT

Spironolactone DRUG

Spironolactone 50mg/day followed by 100mg/day,Dose will be increased as necessary up to 200mg/day.

Spironolactone+SMT

Standard Medical Treatment OTHER

1. Salt restricted diet, high protein diet 2. Patient education 3. Use of loop diuretics as indicated and tolerated 4. Glycemic control in diabetic subjects- SGLT2 inhibitors/DPP4 inhibitors/ GLP-1 analog +/- insulin 5. Managing complications of liver disease 6. Albumin infusions as and when required as per physician's discretion. 7. Use of Beta blockers as indicated and tolerated.

Finerenone+SMT; Spironolactone+SMT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years \<80years
• Patient of MASLD/ NAFLD cirrhosis with clinical ascites
• Stable eGFR-(\>60 ml/min/1.73m2) calculated using MDRD-6 equation: eGFR (ml/min/1.73 m2) = 170 × (Scr)-0.999 × (Age)-0.176 × (0.762 if patient is female) × (1.180 if black) × (SUN)-0.170 × (Albumin)0.318

You may not qualify if:

• Age \<18 years \>80 years
• K/C/O systemic hypertension.
• Coagulopathy- INR \>2.5
• Post TIPS
• CTP class C
• Any intrinsic/structural kidney disease.
• Refractory Ascites
• Patient with HCC(outside MILAN criteria) or portal vein thrombosis
• Pregnancy or Lactating mother
• Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
• Patients with anuria, acute renal failure, or Addison's disease
• Heart failure (NYHA II to IV)
• History of hospitalization for hyperkalaemia or acute renal failure induced by previous aldosterone antagonist treatment
• Ongoing drug or alcohol abuse
• Uncontrolled type 2 DM ( HbA1C \> 9)

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

finerenone; Spironolactone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Dr Vakacherla Lohith, MD

CONTACT

01146300000; lohithvakacherla0910@gmail.com

Dr Rakhi Maiwall, DM

CONTACT

01146300000; rakhi_2011@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: May 13, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-03

Locations

IN (1)